六味地黄丸联合戊酸雌二醇片/雌二醇环丙孕酮片治疗围绝经期综合征的临床研究

目的探讨六味地黄丸联合戊酸雌二醇环丙孕酮片治疗围绝经期综合征的临床效果。方法选取2015年3月—2018年3月成飞医院收治的围绝经期综合征患者262例,随机分成对照组(131例)和治疗组(131例)。对照组口服戊酸雌二醇环丙孕酮片,1片/d,先服白片,再服用红片,无间断连用21 d后停药7 d,进入下一周期。治疗组在对照组基础上口服六味地黄丸,1丸/次,2次/d。两组均连续治疗6个月。观察两组患者临床疗效,同时比较治疗前后两组患者改良Kupperman绝经指数(KMI)评分、腰椎L2～4骨密度、性激素水平、脱氧吡啶啉(D-Pyr)和骨特异性碱性磷酸酶(BALP)水平及绝经期生存质量量表(MENQOL)评分。结果治疗后,对照组临床有效率为88.5%,显著低于治疗组的96.2%,两组比较差异具有统计学意义(P0.05)。治疗后,两组改良KMI评分显著下降(P0.05),腰椎L2～4骨密度显著增高(P0.05),且治疗组这两种指标明显优于对照组(P0.05)。治疗后,两组血清雌二醇(E2)浓度均显著上升(P0.05),血清BALP、卵泡刺激素(FSH)、促黄体生成素(LH)水平和D-Pyr浓度均显著降低(P0.05),且治疗组患者这些指标水平明显好于对照组患者(P0.05)。治疗后,两组患者MENQOL各评分及其总分均显著降低(P0.05),且治疗组患者MENQOL评分明显低于对照组患者(P0.05)。结论六味地黄丸联合戊酸雌二醇环丙孕酮片治疗围绝经期综合征可有效缓解患者绝经症状,提高骨密度,纠正骨代谢紊乱。

Clinical study on Liuwei Dihuang Pills combined with estradiol cypropanone glutarate tablets in treatment of perimenopausal syndrome

Objective To investigate the clinical effect of Liuwei Dihuang Pills combined with estradiol cypropanone glutarate tablets in treatment of perimenopausal syndrom. Methods Patients (262 cases) with perimenopausal syndrome in Chengfei Hospital from March 2015 to March 2018 were randomly divided into control (131 cases) and treatment (131 cases) groups. Patients in the control group were po administered with Estradiol Valerate Tablets, Estradiol Valerate and Cyproterone Acetate Tablets, 1 tablet/time, firstly taken the white pills and then the red pills, continuous treatment for 21 d, then withdraw 7 d, and treated for the next cycle. Patients in the treatment group were po administered with Liuwei Dihuang Pills on the basis of the control group, 1 pill/time, twice daily. Patients in two groups were treated for 6 months. After treatment, the clinical efficacy was evaluated, and the modified KMI scores, lumbar L2~4 bone density, the sex hormone levels, the levels of D-Pyr and BALP, and MENQOL scores in two groups before and after treatment were compared. Results After treatment, the clinical efficacy in the control group was 88.5%, which was significantly lower than 96.2% in the treatment group, and there were differences between two groups (P<0.05). After treatment, the modified KMI scores in two groups were significantly decreased (P<0.05), but lumbar L2-4 bone density was significantly increased (P<0.05), and these two indexes in the treatment group were significantly better than those in the control group (P<0.05). After treatment, the serum E2 concentration in cerebrospinal fluid in two groups were significantly increased (P<0.05), but the serum BALP, FSH, LH levels and urine D-Pyr concentration were significantly decreased (P<0.05), and these indexes in the treatment group were significantly better than those in the control group (P<0.05). After treatment, the each score of MENQOL and total score in two groups were significantly decreased (P<0.05), and which in the treatment group were significantly lower than that in the control group (P<0.05). Conclusion Liuwei Dihuang Pills combined with estradiol cypropanone glutarate tablets in treatment of perimenopausal syndrome can effectively relieve perimenopausal syndromes, improve bone density, correct bone metabolism disorder.